Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

NCT00537979 | Completed Phase 4 Results

• 1 other identifier: W10-129
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 12

Brief Summary

Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.

Conditions

Secondary Hyperparathyroidism; Dialysis

Keywords

Dialysis; Hyperparathyroidism; Zemplar

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level

  Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.

  24 weeks

Secondary Outcomes (5)

• Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)

  24 Weeks

• Proportion of Subjects Who Achieve an iPTH <300 pg/mL

  24 weeks

• Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level

  24 weeks

• Duration of Response to Treatment

  24 weeks

• Health-related Quality of Life With Paricalcitol Injection or Oral Treatment

  Baseline and 24 weeks

Study Arms (2)

Paricalcitol injection

ACTIVE COMPARATOR

ABT-358 Zemplar

Drug: Paricalcitol injection

Paricalcitol capsules

ACTIVE COMPARATOR

ABT-358 Zemplar

Drug: Paricalcitol capsules

Interventions

Paricalcitol injection DRUG

Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Also known as: ABT-358, paricalcitol, Zemplar

Paricalcitol injection

Paricalcitol capsules DRUG

Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Also known as: ABT-358, paricalcitol, Zemplar

Paricalcitol capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>=18 years with secondary hyperparathyroidism (iPTH \>= 300 pg/mL)
• Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
• Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
• Patients providing their signed informed consent to participate in the trial

You may not qualify if:

• Patients with severe hyperparathyroidism (iPTH \> 3,000 pg/ml)
• Patients with hypercalcaemia (calcium \>=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus \>= 6.5 mg/dl) or patients with calcium x phosphorus \>= 70
• Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
• Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
• Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum
• Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D

Sponsors & Collaborators

• Abbott: lead

Study Sites (12)

Site Ref # / Investigator 19391

Jojutla Morelos, CP 62900, Mexico

Location

Site Ref # / Investigator 19392

Mexico City, CP 01030, Mexico

Location

Site Ref # / Investigator 19397

Mexico City, CP 02080, Mexico

Location

Site Ref # / Investigator 19396

Mexico City, CP 03650, Mexico

Location

Site Ref # / Investigator 19389

Mexico City, CP 03900, Mexico

Location

Site Ref # / Investigator 19390

Mexico City, CP 14000, Mexico

Location

Site Ref # / Investigator 19393

Mexico City, CP 14080, Mexico

Location

Site Ref # / Investigator 19394

Mexico City, CP 14140, Mexico

Location

Site Ref # / Investigator 19395

Mexico City, CP 16070, Mexico

Location

Site Ref # / Investigator 19399

Puebla City, CP 72400, Mexico

Location

Site Ref # / Investigator 19398

Zapopan, CP 45116, Mexico

Location

Site Ref # / Investigator 19388

Zapopan, CP 45150, Mexico

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Hyperparathyroidism

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Jose-Luis Cañadas, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 2, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 25, 2011
• Results First Posted: October 25, 2011

Record last verified: 2011-09

Locations

ME (12)